NCT07228455

Brief Summary

Subacromial impingement syndrome is a common musculoskeletal disorder. Therefore, to improve the shoulder biomechanics affected by the syndrome, an intervention group was compared with a control group. The exercise program applied to the intervention group is expected to improve the function of the shoulder complex.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

September 29, 2025

Last Update Submit

November 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acromio-humeral Distance (Ultrasonography, USG)

    Baseline and 6 weeks

Secondary Outcomes (6)

  • Tendon Thickness Measurment

    Baseline and 6 week

  • Pain (Visual Analog Scale, VAS)

    Baseline and 6 weeks

  • Pain (McGill Pain Questionnaire-Pain Rating Index)

    Baseline and 6 weeks

  • Kinesiophobia (Fear Avoidance Beliefs Questionnaire - FABQ, Physical Activity subscale)

    Baseline and 6 weeks

  • Kinesiophobia (Fear Avoidance Beliefs Questionnaire - FABQ, Work subscale)

    Baseline and 6 weeks.

  • +1 more secondary outcomes

Study Arms (2)

The Intervention Group

EXPERIMENTAL

The Intervention group underwent a progressive resistance exercise program to strengthen the humeral head depressors and peri-articular muscles, including the rotator cuff. The exercises were performed 3 times per week for 6 weeks, with each session lasting approximately 1 hour

Behavioral: Humeral Head Depressor Exercises

The Control Group

ACTIVE COMPARATOR

Participants in the control group received standard physical therapy and rehabilitation as usually applied in routine care. Sessions were performed 3 times per week for 6 weeks, each lasting approximately 1 hour.

Behavioral: Standard physical therapy

Interventions

The Intervention group underwent a progressive resistance exercise program to strengthen the humeral head depressors and peri-articular muscles, including the rotator cuff. Exercises were performed 3 times per week for 6 weeks, each session lasting approximately 1 hour

The Intervention Group

Participants in this group received standard physical therapy and rehabilitation as usually applied in routine care. Exercises were performed 3 times per week for 6 weeks, each session lasting approximately 1 hour. Outcomes were measured at the same time points as the intervention group.

The Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers who complained of shoulder pain for more than a month,
  • Who had limitation in passive movement compared to the other side shoulder,
  • Who had Neer impingement test, Hawkins test, Jobe supraspinatus test, and -
  • Who were able to com-municate were included in the study

You may not qualify if:

  • Having any neurological condition affecting the upper extremity,
  • Having neuro-logical findings related to cervical disc herniation,
  • Having a full-thickness rupture of one of the rotator cuff tendons,
  • Having calcific tendonitis,
  • Having undergone previous shoulder surgery,
  • Physical therapy-rehabilitation for the shoulder with the same complaints in the last 6 months,
  • Receiving corticosteroid injection were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Near East University Hospital

Nicosia, Cyprus

Location

Related Publications (1)

  • Kurtaran U, Yerlikaya T, Yenen B, Ozgul A. The Effect of Humeral Head Depressor Strengthening on Individuals with Subacromial Impingement Syndrome. Medicina (Kaunas). 2025 Nov 19;61(11):2061. doi: 10.3390/medicina61112061.

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Ahmet OZGUL, Prof.

    Department of Physical Medicine and Rehabilitation, Kyrenia University Hospital, Kyrenia, Cyprus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded to their group assignment, but therapist were aware of the group allocations
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were quasi-randomly and sequentially assigned to either an intervention group receiving humeral head depressor exercises or a control group receiving routine exercise therapy. Each group followed their respective program for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2025

First Posted

November 14, 2025

Study Start

July 3, 2023

Primary Completion

July 3, 2024

Study Completion

July 3, 2024

Last Updated

November 14, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

The individual participant data from this study will not be shared.

Locations